Milan, July 4th 2022

Doppel Pharma CDMO is pleased to announce that on June 24th, it has delivered to Dipharma the first commercial batches of generic temperature stable Nitisinone capsules to be commercialized in the USA.

Nitisinone is used to treat adult and pediatric patients with a confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restrictions. Since its use as the first-line treatment of HT-1, nitisinone has replaced liver transplantation for this rare condition. Nitisinone Dipharma has already been approved and launched in several European countries.

The collaboration between Doppel Pharma CDMO and Dipharma for the development of this new temperature stable formulation and its commercial production started back in 2015, culminating into a Drug Product that is bioequivalent to the originator (Swedish Orphan Biovitrum’s Orfadin®) with the advantage it does not require to be stored under refrigerated conditions

“This is the first product manufactured by Doppel to be launched in the USA.” Dr. Giorgio Oberrauch, Doppel Pharma CEO said “We are very excited to have reached this milestone together with Dipharma. I consider the achievement the confirmation of a leadership position in the CDMO arena, that Doppel has been building over the last few years. Moreover, this underlines the commitment that Doppel has taken towards working with its partners and customers in developing therapeutic options to Rare Diseases

Nitisinone capsules will be commercialized by Dipharma’s partner Analog Pharma through specialty pharmacies starting from Q3 2022.

FDA report: